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SGN-35

Phase 1

Lymphoma, Non-Hodgkin | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Dec 18, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00430846Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic MalignanciesPHASE1 COMPLETED 45Nov 1, 2006Jul 1, 2009Dec 18, 20144 United States
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Study Endpoints
Primary Endpoints
Incidence of adverse events and laboratory abnormalities
1 month after last dose
Secondary Endpoints
PK profile
2 months after last dose
Immunogenicity (anti-SGN-35 antibodies)
1 month after last dose
Anti-tumor activity
1 month after last dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
Interventions
NameTypeDescription
SGN-35DRUGEvery 21 days. Dose Escalating. 0.1 - 3.6 mg/kg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Patients must have histologically confirmed CD30-positive hematologic malignancy. * Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ine...

Countries:United States
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